Pfizer and BioNTech’s Comirnaty XXB.1.5-adapted COVID-19 vaccine has been approved by the European Commission (EC) for adults, children and infants aged over six months.
The authorisation follows a positive opinion from the European Medicines Agency’s human medicines committee, which recommended marketing authorisation for a single dose of the vaccine in eligible individuals aged five years and older, regardless of their COVID-19 vaccination history
The committee also recommended that children aged from six months to four years may have one to three doses of the updated vaccine, depending on their previous primary vaccination and whether they have had COVID-19.
The decision was based on evidence from pre-clinical data, which showed that the updated vaccine generated a substantially improved response against multiple XBB sublineages of the SARS-CoV-2 virus variants compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
Comirnaty XBB.1.5 also showed efficacy against the EG.5.1 variant, otherwise known as Eris, which was designated by the World Health Organization as a ‘variant of interest’ in August.
“Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally,” said Professor Ugur Sahin, chief executive officer and co-founder of BioNTech. “The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalisation.”
Pfizer and BioNTech have previously said that doses of the updated vaccine will be ready to ship immediately upon authorisation by the EC.
Albert Bourla, chairman and chief executive officer at Pfizer, said: “This season’s vaccine is ready to ship as soon as the final regulatory decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises.”
The Comirnaty XBB.1.5-adapted COVID-19 vaccine is currently the third adaptation of this vaccine to respond to new COVID-19 variants.
The companies have also filed an application with the US Food and Drug Administration (FDA) for the approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine in individuals aged six months and older.
In June, the FDA advisory committee recommended that updated COVID-19 vaccines be developed to target the currently circulating XBB variants.
The Vaccines and Related Biological Products advisory committee voted 21 to zero in favour of the monovalent XBB-lineage vaccines and generally agreed that vaccines targeting the XBB. 1.5 subvariant would be preferred.